Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Janssen
INDICATIONS [/za_1199.html#1] [/za_1199.html#1] [/za_1199.html#1] CONTRA-INDICATIONS [/za_1199.html#1] [/za_1199.html#1] DOSAGE [/za_1199.html#1] [/za_1199.html#1] SIDE-EFFECTS [/za_1199.html#1] [/za_1199.html#1] [/za_1199.html#1] PREGNANCY [/za_1199.html#1] [/za_1199.html#1] OVERDOSE [/za_1199.html#1] IDENTIFICATION [/za_1199.html#1] [/za_1199.html#1] PATIENT INFORMATION GYNOSPOR VAGINAL CREAM SCHEDULING STATUS: S2 PROPRIETARY NAME (and dosage form): GYNOSPOR VAGINAL CREAM COMPOSITION: Each gram contains: MICONAZOLE Nitrate 20 mg PRESERVATIVE: Benzoic acid 0,2% m/m ANTI-OXIDANT: Butylated hydroxyanisole BP 0,0052% m/m PHARMACOLOGICAL CLASSIFICATION: A 18.6 Medicines acting on the genito-urinary system. Vaginal preparations. PHARMACOLOGICAL ACTION: Miconazole nitrate is a synthetic 1-phenethylimidazole derivative. In vitro, low concentrations of miconazole nitrate are fungistatic against all Phycomycetes, Ascomycetes and Adelomycetes tested (e.g. Saprolegnia, Candida, Cryptococcus, Aspergillus, Dermatophytes, Phialophora, Sporotrichum) and fungicidal against Trichophyton mentagrophytes, Trichophyton rubrum, Epidermophyton floccosum, Trichophyton interdigitale and Micosporum canis. Thus GYNOSPOR VAGINAL CREAM is a broad-spectrum antifungal agent. Miconazole nitrate also possesses some antimicrobial activity against gram positive bacilli and cocci. PHARMACOKINETICS: Systemic absorption after intravaginal administration is limited. INDICATIONS: For the relief of vaginal itching, burning and discharge associated with recurrent vaginal yeast infections. CONTRA-INDICATIONS: Contra-indicated in individuals who have shown hypersensitivity to miconazole nitrate and other ingredients in the cream. WARNINGS: Use only if you have the same symptoms as previously diagnosed (by a medical practiti Read the complete document